Pilot study used to access bioequivalence [Regulatives / Guidelines]

posted by Marcel – 2011-04-13 17:26 (5556 d 09:35 ago) – Posting: # 6898
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Opps, seems we double posted and I didn't have a chance to thank you too, so thank you.

I'm drafting a response for the CMD as we speak. I'll mention something about the "unethicalness" of repeating a study.

The rest is up to par. Everything is as it should be, but we are dealing with a very stubborn (and rude) assessor.

Cheers.

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